Provides overall leadership for clinical and basic science research operations within the Department of Surgery.
Plans, organizes, directs and oversees daily operations of clinical and basic science research operations, patient recruitment practices, medical partnering, tracking administrative and regulatory aspects of multiple research studies conducted at multiple sites.
Assists in developing and executing strategic and operational plans for clinical and basic science research.
Serves as a resource to investigators and section administrators on budgeting, contract negotiations, feasibility assessments, compliance, and best practices.
Develops, manages, and reports on key data.
Ensures timeliness of data and reporting submissions from multiple investigators; establishes and implements consistent standards and protocols.
Ensures ongoing competence of study coordinators in the department, with both direct and indirect lines of reporting authority.
Liaises with University Research Administration, Institutional Review Board, Office of Clinical Research, and other key constituents throughout the University.
Supervises all pre-award and regulatory activity and staff, including the preparation of all administrative aspects of grant and contract applications in accordance with Institutional and Agency Guidelines.
Serves as the project manager to gather all required pieces for a successful grant submission, working directly with the Principal Investigators, co-investigators, and other research staff.
Serves as resources for faculty and research staff on regulatory board protocol submissions.
Works with others to identify strategies to increase external support for basic science or clinical research activities.
Works closely with Post Award individuals to transition grant administration upon award, including updating proposed budget to match Notice of Grant Award.
Establishes new laboratories and provides assistance with purchasing new laboratory equipment.
Ensures efficient operations of departmental laboratory space.
Oversees maintenance and repair of laboratory equipment.
Ability to work in a complex healthcare delivery system.
Ability to synthesize complex clinical and basic science research information into messages that are readily understandable by a wide audience of individuals.
Ability to readily understand and apply industry terminology and practical research implications, building rapport and communicating effectively with medical professionals in a broad spectrum of sub-specialties.
Familiarity with general business practices and financial analysis.
Commitment to providing a high level of service and working in a team environment.
High degree of professionalism.
Attention to detail.
Ability to handle confidential information with the utmost discretion.
Excellent interpersonal, verbal, and written communication skills.
Ability to handle multiple tasks simultaneously and under tight deadlines.
Strong analytical and organizational skills.
Lab management skills.
Advanced knowledge in relevant scientific field.
Advanced knowledge of research techniques or methods.
Knowledge of scientific applications and equipment.
Knowledge of regulatory policies and procedures.
Knowledge of Microsoft Office.
Education, Experience or Certifications:
Education and Certifications:
An advanced degree in a field relevant to medicine, nursing, or the biological sciences with at least three years of clinical trials program development and coordination experience OR a Bachelor's degree in a field relevant to medicine, nursing or the biological sciences with at least seven years of clinical trials program development and coordination experience OR a RN with at least five years of clinical trials program development and coordination experience required.
Completion of CRC, CCCP, CCRP, or Graham School Clinical Trial Management certification program preferred.
Experience with a variety of trial types (sponsored, investigator initiated, cooperative groups, etc.) preferred.
Broad based experience with clinical and basic science research, including consenting, IRB submissions /correspondence, and audit preparations preferred.
Experience with grants and contract administration pre, post and regulatory preferred.
Experience within academic medical environment preferred.
Program planning, implementation, and evaluation experience preferred.
Reference Contact Information
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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